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Berlin Heart EXCOR Series Instructions For Clinical Use

Ventricular assist device active driving system
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®
EXCOR
VAD
Ventricular Assist Device
®
EXCOR
Active Driving System
Instructions for Clinical Use
Edition 1.0
EXCOR
Adult
EXCOR
Pediatric
®
®

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Summary of Contents for Berlin Heart EXCOR Series

  • Page 1 ® EXCOR Ventricular Assist Device ® EXCOR Active Driving System Instructions for Clinical Use Edition 1.0 EXCOR Adult EXCOR Pediatric ® ®...
  • Page 2 1015002x00...
  • Page 3 These instructions for use may not be reproduced, forwarded, transmitted by electronic media, stored in a data processing system or translated into another language, either wholly or in part, without the written consent of Berlin Heart GmbH. These instructions for use are intended for information purposes only. The contents of the instructions for use may be supplemented, modified or updated at any time without prior notice.
  • Page 4 These rights are expressly recognized and respected when referring to these names in the pres- ent publication. Use of the trademark will be dispensed with in the further text. Berlin Heart GmbH will be hereinafter referred to as Berlin Heart.

  • Page 5: Table Of Contents

    Table of Contents Table of Contents Contact Introduction Target Audience ....................... 15 Explanation of the Safety Information and Signal Words ..........15 Terms ..........................16 Meaning of Text Markups ....................17 Pictograms on Components ..................... 17 2.5.1 Safety Symbols ......................17 2.5.2 Symbols........................
  • Page 6 Table of Contents 5.2.3.3 Attaching the Flow Sensors to the Cannulae and the Blood Pumps...... 45 5.2.3.4 Removing the Flow Sensor from the Cannula............46 5.2.3.5 Replacing the Sensor Quick Connect ..............46 5.2.3.6 Connecting/Disconnecting the Flow Sensor to/from the Driving Unit..... 46 5.2.3.7 Guiding the Driving Tube and the Flow Sensor Cable in the Cable Wrap .....
  • Page 7 Table of Contents 7.1.1 File and Menu Bar ....................... 74 7.1.2 Status Bar........................75 7.1.3 Buttons ........................76 Functions of the Menu Bar ....................77 7.2.1 User Login ........................77 7.2.2 Passwords ........................79 7.2.3 User Log Off ........................ 79 Monitoring.........................
  • Page 8 Table of Contents 8.6.5.3 Piston Stroke and Mean Driving Pressure ............106 8.6.5.4 Optimizing Filling and Emptying ................106 8.6.6 Setting the Parameter Duration Systole ..............107 8.6.7 Displaying the Pressure Curves ................107 8.6.8 Resetting the Driving Unit..................108 Measuring the Blood Flow ....................
  • Page 9 Table of Contents 13.1 Setup ..........................135 13.2 Assembly - Disassembly ....................135 13.2.1 Adjusting the Stand ....................135 13.2.2 Mounting - Dismounting the Wheels................136 13.2.3 Inflating the Tires ....................... 136 13.2.4 Attaching the Accessory Bag..................137 13.2.5 Fastening the Hand Strap ..................137 13.2.6 Adjusting the Handle Height ..................
  • Page 10 Table of Contents 17.3.7 Audible Alarms on the Driving Unit................158 17.3.8 Audio Off ........................159 17.3.9 Saving Configurations and Logs................159 17.3.10 Canceling an Alarm ....................159 17.4 Reacting to Driving Unit Alarms..................159 17.5 Driving Unit Alarms......................160 17.5.1 Alarms on the Driving Unit..................
  • Page 11 Table of Contents Overview - Parameters 21.1 Parameters - Blood Pumps and Cannulae ..............195 21.2 Permitted BVAD Combinations ..................195 21.3 Permitted Combinations of Blood Pumps and Cannulae ..........196 21.4 Patient and Driving Unit....................196 Using the External Alarm (Nurse Call) 22.1 Assembling the External Alarm (Nurse Call) Adapter.............
  • Page 12 Table of Contents 1015002x00...

  • Page 13: Contact

    +49 (0)30 81 87 27 72 Medical and technical assistance for 24 hours a day, every day medical personnel Manufacturer Berlin Heart GmbH Tel.: +49 (0)30 8187 2600 Wiesenweg 10 Mon - Fri 8:00 am - 6:00 pm 12247 Berlin...
  • Page 14 Contact 1015002x00...

  • Page 15: Introduction

    Indicates practices that will not result in personal injury. The device may suffer damage. ADVICE Indicates corrective actions and work techniques that are recommend- ed by Berlin Heart. Heed the instructions for use on EXCOR sterile components! Reference to explanations in the EXCOR Sterile Components instructions for use. HOTLINE...

  • Page 16: Terms

    Introduction Terms EXCOR EXCOR VAD and its corresponding driving sys- tems EXCOR VAD Paracorporeal VAD system consisting of blood pumps, cannulae, cannulae extension set, con- necting set, and accessories EXCOR Pediatric EXCOR VAD system components approved for pediatric use EXCOR Adult The EXCOR VAD system components approved for use on adult patients EXCOR Active...

  • Page 17: Meaning Of Text Markups

    Introduction Meaning of Text Markups Instructions: Read the instructions completely. Carry out steps as instructed. Explanations of emphases Formatting Meaning Parameter Denotes a parameter (except in headers or directories) Indicates a menu or a button on the user interface. Button labels <Button>...

  • Page 18: Symbols

    Introduction 2.5.2 Symbols Electrical or electronic device; Order number do not dispose with household waste. Only use and store in a dry Lot number environment. Applied part, cardiac floating Serial number type Defibrillation-proof applied Manufacturer part, cardiac floating (CF) type Date of manufacture Use by Temperature limitation with...

  • Page 19: General Information Excor Active

    General Information EXCOR Active General Information EXCOR Active System Overview - Driving Unit with EXCOR VAD Together, the driving unit and the components of the EXCOR VAD system form an ex- tracorporeal, pulsatile ventricular assist device. The components that are continuously active on the patient are •...

  • Page 20: Components And Locations Of Use

    General Information EXCOR Active Components and Locations of Use Mobile components for use in the Stationary components for use in the hospital and healthcare environ- hospital, suitable for indoor use ments, suitable for use in indoor and outdoor areas Driving unit Battery charging unit Flow sensor with cable wrap Power Supply Unit for Driving Unit and...

  • Page 21: Intended Use

    All decisions regarding the selection of components as well as the care of the patient are the sole responsibility of the treating physician. The recommendations made in these instructions for use are based on the experiences of Berlin Heart. Before thera- py with the EXCOR system, the treating physician must conduct a medical evaluation of the mental and physical compliance of the patient.

  • Page 22: Indications, Contraindications, And Potential Therapeutic Objectives

    General Information EXCOR Active 3.4.2 Indications, Contraindications, and Potential Therapeutic Objec- tives The indications, contraindications, and potential therapeutic objectives for EXCOR VAD apply to EXCOR Active in connection with EXCOR VAD. These are de- scribed in the EXCOR Sterile Components instructions for use. Heed the instructions for use on EXCOR sterile components! EMC - Electromagnetic Compatibility EXCOR Active is shielded against electromagnetic radiation, including both electro-...

  • Page 23: Replacement Components

    General Information EXCOR Active Impermissible combinations Combination with the following diagnostic procedure is not allowed: • magnetic resonance imaging Permitted Combination with the following diagnosis/therapy procedures is permitted: • high-frequency surgery, diathermy (flow measurement may be disrupted for the duration of the high-frequency surgical procedure). •...

  • Page 24: Product Life

    General Information EXCOR Active Medical waste Dispose of explanted cannulae, used blood pumps, and contaminated disposable items in accordance with the valid local, state, and national laws and guidelines re- garding medical waste. 3.10 Product Life Component Product life in years Driving unit Battery Power Supply Unit for Driving Unit and Battery...

  • Page 25: Safety Information

    Components made by other manufacturers may only be used together with EXCOR Active if their use is specified in the instructions for use, and if the components are supplied by Berlin Heart. Only use, handle, and service the components of the EXCOR Active system appropriately, as described in the instructions for use.

  • Page 26: Caregivers

    Safety Information Have an EXCOR Active or an Ikus on hand in the hospital at all times as a backup. Medical personnel must be trained in the use of the back- up system. Medical personnel must be available in the hospital at all times.

  • Page 27: Diagnostic Procedures, Emc

    Safety Information Do not use EXCOR Active in the vicinity of flammable gases! Otherwise there is a risk of explosion from ignition of the gas mixture. Observe correct storage conditions for all EXCOR System compo- nents, see section 20.9.2: Storage Conditions, page 193. Failure to maintain correct storage conditions could damage components, short- en product life, and delay usability in emergency situations.

  • Page 28: Power Supply

    Safety Information Only connect electrical components to fixed mains power outlets. Do not use extension cables. Take into account the protection class of the power outlet and components! Do not touch the electrical contacts on a component and the patient at the same time.

  • Page 29: Driving Unit Structure And Function

    Driving Unit Driving Unit Structure and Function 5.1.1 Primary Function The driving unit contains two pneumatic units. Each pneumatic unit consists of one cylinder, inside of which a piston moves. The piston motion alternately produces driv- ing and suction pressures. These alternating pressures are transferred to the blood pump via the driving tube.

  • Page 30: Setup

    Driving Unit The driving unit can be operated using mains power or two batteries. An integrated emergency battery is available as reserve. 5.1.2 Setup 1 Control panel 2 Handle 3 Batteries 4 USB port cover (connection to Panel 5 External alarm (nurse call) cover 6 Air vents Fig.

  • Page 31: Connections And Operation Elements

    Driving Unit Connections and Operation Elements 5.2.1 Control Panel The control panel is divided into two sides. The red side is used to control left circula- tory support, and the blue side controls right circulatory support. The connection for the power supply unit is located in the middle. The red and blue drive sides have identical setups.

  • Page 32: Display

    Driving Unit Switching off the driv- Both buttons view is displayed. HUTDOWN ing unit simultaneously for The driving unit can be switched off around five sec- by disconnecting the mains or onds removing both batteries. For shut- down information, see also section 5.6: Switching Off the Driv- ing Unit, page 50.
  • Page 33 Driving Unit Symbol Significance LARM An alarm condition is in place. The driving unit emits audible alarm signals. Once the alarm condition has been rectified, the symbol dis- appears. If the <button> is pressed, the display switches to UDIO PAUSED UDIO PAUSED An alarm condition is in place.
  • Page 34 Driving Unit Views The display has six views. The views are arranged in a fixed order. Use the contents of the display area, the view marker, and the view symbol in the bottom right to deter- mine which view is currently being shown. The views may LARM LARM HISTORY...
  • Page 35 Driving Unit Error view 1 Alarm paused 2 Display of current errors; error 1 of 2 is currently being displayed 3 Display of error codes and mes- sage Fig. 5-8 Display of view – Error Error messages are displayed on the Start screen. When the button is pressed, audi- ble alarms are paused, and the view is shown.
  • Page 36 Driving Unit Fig. 5-10 Display of view – Info Maintenance view Displays information regarding and the driving unit software version. AINTENANCE 1 Driving unit software version 2 Expected date of next mainte- nance 3 Pump cycles Fig. 5-11 Display of view – Maintenance The following is displayed: pump cycles conducted / number of cycles after which maintenance is required...
  • Page 37 Driving Unit 1 Error code 2 Date 3 Duration of the alarm Fig. 5-12 Display of view – Maintenance For each error, the • error code and message text (no message text with non-verbal setting) • date and time of occurrence •...

  • Page 38: Connections

    Driving Unit 1 Emergency battery charge level Fig. 5-14 Display view – Charge emergency battery Start test Fig. 5-15 Display view – Start test A driving unit that has not yet been configured will automatically perform a start test upon starting up, see section 5.4: Start Test for the Driving Unit, page 50. 5.2.2 Connections WARNING...

  • Page 39: Overview Of Connections

    Driving Unit 5.2.2.1 Overview of Connections 1 Driving tube left blood pump 2 Flow sensor left blood pump 3 Power supply unit connection (under the cover) 4 Driving tube right blood pump 5 Flow sensor right blood pump Fig. 5-16 Connections on the control panel 1 USB, connection to the panel PC 2 Connection adapter for external alarm (nurse call)

  • Page 40: Connecting The Power Supply Unit To The Driving Unit

    Driving Unit 5.2.2.3 Connecting the Power Supply Unit to the Driving Unit Open the cap. Grasp the connector plug by its ribbed body (1). Align the markings on the con- nector plug and the connector. Insert the connector plug into the connector.

  • Page 41: Connecting The External Alarm (Nurse Call) Adapter

    Driving Unit Insert the USB cable into the panel PC or docking station. 3 USB cable on panel PC 5.2.2.6 Connecting the External Alarm (Nurse Call) Adapter The adapter for the external alarm (nurse call) connects the driving unit with a hospital alarm system.

  • Page 42: Setup

    Driving Unit The flow measurement displayed may deviate from the actual flow, see Tab. 5-2 , page 44. Use only flow progression over time for diagnostic purposes, see section 7.7.2: Trend Info, page 91. Progression over time is only mean- ingful provided that other conditions (parameters, blood pumps, driving unit, flow conditions within cannulae) have remained the same.
  • Page 43 Driving Unit 1 Cannula 2 Flow sensor 3 Sensor locking clip 4 Protective cap 5 Mirror 6 Sensor quick connect 7 Stop 8 Sensor cable Fig. 5-20 FS06-06-P flow sensor on a 6 mm cannula Sensor models There are matching flow sensors for the different cannula sizes and blood pumps. The flow sensor label indicates the cannula-blood pump combination for which the flow sensor is designed.

  • Page 44: Measurement Accuracy And Alarms

    Driving Unit Example • FS - Flow sensor • 06 - 6 mm cannula diameter • 06 - 6 mm blood pump connector • P - For blood pumps with tri-leaflet polyurethane valves Only use the intended flow sensors. Flow sensors that are too small could pinch the cannulae.

  • Page 45: Attaching The Flow Sensors To The Cannulae And The Blood Pumps

    Driving Unit Measurement accuracy within the measurement range FS12-12-P ± 15% within the range of 3.0 l/min to 8.0 l/min FS12-12-C Tab. 5-2 Flow measurement accuracy The flow rate shown is the mean value over five pumping cycles. If that flow rate drops below the flow alarm threshold, an alarm is emitted.

  • Page 46: Removing The Flow Sensor From The Cannula

    Driving Unit 5.2.3.4 Removing the Flow Sensor from the Cannula Open the sensor quick connect (1). Pinch the sensor locking clip (2) together at the top. Remove the sensor locking clip. Remove the flow sensor from the cannula. Fig. 5-25 Removing the flow sensor 5.2.3.5 Replacing the Sensor Quick Connect Attach the sensor quick connect (1) to the flow sensor.

  • Page 47: Guiding The Driving Tube And The Flow Sensor Cable In The Cable Wrap

    Driving Unit 5.2.3.7 Guiding the Driving Tube and the Flow Sensor Cable in the Cable Wrap Draw the cable wrap up from the blood pump toward the driving unit. Align the driving tube and sen- sor cable. Insert the driving tube and the sensor cable into the wrapping tool.

  • Page 48: Removing The Cable Wrap

    Driving Unit 5.2.3.8 Removing the Cable Wrap Remove the cable wrap starting from the driving unit in the direc- tion of the blood pump. Always hold the driving tube and sensor cable together. Pull the driving tube and sensor cable out of the cable wrap.

  • Page 49: Driving Unit Setup

    Driving Unit 5.2.4.1 Driving Unit Setup 1 Handle 2 Mounting bracket 3 Mount • Handle: The handle is used to carry the driving unit as well as to lock the driving unit onto the transport system. Pulling out the handle releases the lock. Pushing it in sets the lock.

  • Page 50: Start Test For The Driving Unit

    Driving Unit Start Test for the Driving Unit A driving unit that has not yet been configured will automatically perform a start test upon starting up. The start test is a routine used to check driving unit functionality. The start test lasts a maximum of one minute. Once the start test has completed without errors, the driving unit is ready.

  • Page 51: Power Supply

    Driving Unit If the Shutdown symbol appears but power supply is not interrupted, the driving unit will continue running. The driving unit cannot only be switched off by disconnecting the mains and removing both batteries. If the driving unit’s power supply is interrupted, the emergency battery will power the driving unit.

  • Page 52: Inserting The Batteries

    Driving Unit The battery charge level display allows users to estimate how much longer the system can be used in mobile operation. This is a guideline value. Factors that determine the duration of mobile use: chapter 5.7.1.9: Driving Unit Operating Time in Battery Operation, page 56.

  • Page 53: Removing The Batteries

    Driving Unit 5.7.1.2 Removing the Batteries To remove a battery, reach into the recessed grip. Press the button on the grip upwards. Pull the battery upwards to remove it. When the driving unit is being used with a patient, never remove more than one battery at a time.

  • Page 54: Checking The Battery Charge Level

    Driving Unit 5.7.1.7 Checking the Battery Charge Level The charge level of a battery can be read: • on the battery, by pressing the <charge level button> • on the corresponding driving unit display • on the panel PC The charge level display is located on the top of the battery. Next to it is the <charge level button>.

  • Page 55: Determining The Charge Level

    Driving Unit 5.7.1.8 Determining the Charge Level Charge level provides a basis for estimating the driving unit’s approximate operating time. Charge level is displayed on components as follows: Relative Driving unit and Battery Battery Emer- Battery state of panel PC dischar- char- gency...

  • Page 56: Driving Unit Operating Time In Battery Operation

    Driving Unit 5.7.1.9 Driving Unit Operating Time in Battery Operation The operating time of the driving unit depends primarily on the operating mode, the size of the blood pump, the set rate, and the ambient temperature. The cannulae in use, the systolic duration, and the patient’s pre- and afterloads all affect operating time as well.

  • Page 57: Notes On Replacing The Batteries

    Driving Unit Influencing factors Operating time of the driving unit in battery operation BVAD, LVAD or RVAD In BVAD operating mode, both pneumatic units are operating mode operated, whereas only one is operated in LVAD or RVAD mode. As such, system operating time is comparatively longer in LVAD and RVAD modes.

  • Page 58: Emergency Battery

    Driving Unit 1 Power cable connection 2 Power supply unit 3 Mains operation indicator 4 Power cable (country-specific - the power cable supplied may differ from the one shown) 5 Device connection plug (for connection to the driving unit and the battery charging unit) Fig.

  • Page 59: Battery Charging Unit

    Driving Unit The emergency battery is charging. Pay attention to the symbol. The charging process is complete when all four bars on the symbol are continu- ously displayed. To switch the driving unit off, see section 5.6, page 50. To start a replacement driving unit whose emergency battery is charging: •...

  • Page 60: Function

    Driving Unit illuminated green The battery charging unit is connected to the mains, the battery mount is ready for operation. chaser light The battery is charging. green, steadily illumi- The battery is fully charged. nated orange, flashing The battery is defective and may not be used further.

  • Page 61: Connecting Electrical Components

    Driving Unit Check the charge level on the battery. Press the <charge level button> on the battery and check whether the battery is fully charged. Connecting Electrical Components 8 Docking Station 1 Power supply unit 9 Panel PC power supply unit 2 Adapter for external alarm 10 Battery charging unit 3 Batteries...
  • Page 62 Driving Unit Switching to a configured replacement driving unit Have the patient sit or lie down. Remove the driving unit from the transport system. Compare the patient ID information on the driving unit and the replacement driving unit. The patient ID can be found on the back of the driving unit. Check whether the selected replacement driving unit is intended for the patient.

  • Page 63: Replacing A Driving Unit In Lvad And Rvad Patients

    Driving Unit 5.10.2 Replacing a Driving Unit in LVAD and RVAD Patients 5.10.2.1 Checking the Functionality of an Unconfigured Driving Unit and Panel PC Have the panel PC and driving unit ready. Connect the panel PC to the mains and switch it on. Connect the driving unit to a power supply.

  • Page 64: Replacing The Driving Unit

    Driving Unit If settings need to be changed, switch to the corresponding view. Make the necessary changes. If all settings are correct, press . The settings are copied to the driving PPLY unit. Open the left pneumatic connection for LVAD operation, or the right pneu- matic connection for RVAD operation.

  • Page 65: Bvad Emergency Operation

    Driving Unit In the view, select the tab. Set LOOD PUMP SETTINGS LOW ALARM THRESHOLD Flow alarm threshold. 10. Switch off the driving unit that is no longer in use. For shutdown information, see section 5.6: Switching Off the Driving Unit, page 50. Close all open con- nectors.
  • Page 66 Driving Unit 1015002x00...

  • Page 67: Panel Pc And Docking Station

    Panel PC and Docking Station Panel PC and Docking Station Safety Information WARNING The panel PC is intended for mains operation. Use battery operation only for transportation within the hospital. The panel PC must not be connected to a driving unit that is supporting a patient while the batteries are being replaced.
  • Page 68 Panel PC and Docking Station Charge level display If the panel PC is connected to the mains and if a battery is in the mount, the display will be illuminated. • Green: Battery charged (> 95 %) • Orange: Battery charging •...

  • Page 69: Supplying Power Via Power Supply Unit

    Panel PC and Docking Station Supplying Power via Power Supply Unit The panel PC is designed for mains operation. The panel PC power supply unit can be directly connected to the panel PC or to the docking station. 1 Panel PC power supply unit 2 Plug for panel PC 3 Panel PC power supply unit On / Off display 4 Mains power connector...

  • Page 70: Docking Station

    Panel PC and Docking Station Inserting the battery Open the locking mechanism. To do so, slide the lock toward the right. Place the battery in the mount. Close the locking mechanism. To do so, slide the lock toward the 1 Bolt, right = open left.

  • Page 71: Panel Pc And Docking Station

    Panel PC and Docking Station 3 Charge level display for the battery in the docking station • Green - Battery charged (>95 %) • Orange - Battery is charging 4 Display for the panel PC - docking station connection • Blue - connected •...

  • Page 72: Connecting The Panel Pc To The Driving Unit

    Panel PC and Docking Station Connecting the Panel PC to the Driving Unit 6.6.1 Connection via USB WARNING Only use the USB ports on the panel PC and the docking station for connecting the driving unit and the USB stick. Otherwise, operation of the panel PC could be disrupted.

  • Page 73: User Interface

    User Interface User Interface General The user interface starts when the panel PC is switched on. The user interface allows users to adjust driving unit and panel PC settings. Inactive functions and information are grayed out or hidden. Information on the status of the driving unit and the panel PC is shown in the status bar.

  • Page 74: File And Menu Bar

    User Interface 7.1.1 File and Menu Bar pull-down menu is located on the top left. The File menu contains general functions for operating and configuring the panel PC and driving unit. The menu bar offers access to the most important functions and views of the user in- terface.

  • Page 75: Status Bar

    User Interface CTIVE ALARM High-priority alarms: flashing red bell symbol, error shown along with troubleshooting instructions. Only visible when a high-priority alarm is being signaled. Active medium-priority alarm: flashing yellow bell symbol, error shown along with troubleshooting instructions. Only visible when a medium-priority alarm is signaled and a high-priority alarm is not present at the same time.

  • Page 76: Buttons

    User Interface , USB ISPLAY DATA TRANSFER Animated depiction of data transmission from the panel PC to the USB stick. Only shown if data transmission takes longer than three seconds. RIVING UNIT PANEL CONNECTION not connected connected ELATIVE STATE OF CHARGE AND CHARGING DISPLAY FOR BATTERIES Display of the relative state of charge as well as charge display for the left and right batteries on the driving unit.

  • Page 77: Functions Of The Menu Bar

    User Interface Slider control Slider controls allow parameters to be set by sliding the bar. Values can also be entered using the keypad. The ends of the slider con- trol delimit the possible input values. Keypad Parameter values and symbols can be entered using the keypad.
  • Page 78 User Interface User Use case • Change of settings EDICAL • Display of data • Analysis of historical data • Configuration of a replacement driving unit Precondition: Driving unit and panel PC are connected via USB cable. No user Monitoring of flow and system functions logged in Precondition: Driving unit and panel PC are connected via USB cable.

  • Page 79: Passwords

    User Interface 7.2.2 Passwords Passwords are provided separately for each system. Store passwords in a safe place. Keep passwords secret from unauthorized persons. User Password LOCAL xxxxxx MEDICAL xxxxxx EXPERT xxxxxx 7.2.3 User Log Off To log off the panel PC, press the button.

  • Page 80: Settings For The Blood Pumps

    User Interface Fig. 7-2 Monitoring Bar flow Graphical illustration of the current blood flow Bell Alarm threshold set for the flow alarm in [l/min] Flow Display of the current blood flow in [l/min] Rate Display of the rate in [bpm] Alarm Displays a current active alarm The Monitoring view is available when the panel PC is connected to the driving unit...
  • Page 81 User Interface Fig. 7-3 Settings for the blood pump parameters Parameters for setting the blood pumps Parameter Description Filling / Emptying Optimization of the filling and emptying of the blood pump by changing the piston stroke as well as the suctioning and driving pressures generated.
  • Page 82 User Interface Parameter Description Rate Number of pump cycles [1/min] One pump cycle comprises the suctioning and ejec- tion of blood by the blood pump. In synchronous and asynchronous modes, setting the rate in one blood pump simultaneously sets the rate of the other blood pump.
  • Page 83 User Interface Parameter Description Asynchronous The two blood pumps work asynchronously. When mode one blood pump is in systole, the other blood pump is in diastole. Asynchronous mode can be used with very small patients to minimize intra-thoracic volume displacement. Separate mode Both blood pumps work independently from one another.

  • Page 84: Display Of Pressure Curves

    User Interface Auto / Pause Starts or stops the continuous operation of the left blood pump. Step right With each press of this button, the right blood pump is filled or emptied. Pressing 2x equals one pump cycle. Auto / Pause Starts or stops the continuous operation of the right blood pump.

  • Page 85: Settings For The Driving Unit

    User Interface Settings for the Driving Unit 7.5.1 Patient information and driving unit settings Parameter Description Patient ID Patient ID Driving unit settings (configuration file) and log files are saved under the patient ID. The patient ID is assigned during driving unit configura- tion.

  • Page 86: Blood Pumps And Cannulae

    User Interface Parameter Description Child protection Switching child protection on and off Muting of audible alarms can be delayed by 15 s. To do this, child protection must be activated. Child protection prevents children or unauthorized persons from paus- ing audible alarms before medical personnel or care- givers have an opportunity to hear them.

  • Page 87: Settings - Overview

    User Interface first, select the operating mode in the window. next, se- BLOOD PUMPS AND CANNULAE lect the size of the implanted blood pumps and cannulae. the values entered here are critical for the correct regulation of the suctioning and driving pressures. Parameter Description Operating mode...

  • Page 88: Data

    User Interface Data 7.6.1 Files opens a menu in which ILES • log files can be imported from the driving unit to the panel PC • log files can be exported from the panel PC to a USB stick • log and configuration files can be deleted from the panel PC •...

  • Page 89: System Information

    User Interface Setting the language opens a window listing the available languages. The lan- ANGUAGE FOR PANEL guage can be selected by pressing the corresponding button. Setting date and time opens a window for setting the date and the system time of the panel ATE AND TIME The time is set using two rotary knobs (hours and min- utes).

  • Page 90: Switching Off The Panel Pc

    User Interface The function must be used when one of the following settings is to be amended: • Patient ID • Implantation date • Operating mode • Cannula size The driving unit settings can only be reset when the blood pumps are stopped. 7.6.5 Switching Off the Panel PC Fig.

  • Page 91: Alarm History

    User Interface Alarm History 7.7.1 Progression All past messages can be found under Progression. Tapping the column header will make an arrow appear. Tapping the arrow allows alarms to be sorted according to the corresponding categories. If the panel PC is connected to a driving unit, the alarms for the connected driving unit are displayed.
  • Page 92 User Interface Curve selection Selection window to show or hide parameters for the right and left drive sides. The following can be selected: • systolic pressure (driving unit) • diastolic pressure (driving unit) • flow Patient ID Users logged in as can view all data records OCAL on the panel PC which are assigned to a patient ID.

  • Page 93: Active Alarms

    User Interface Active Alarms The button becomes visible when an alarm is signaled. The button will be flash- ing red, flashing yellow, or continuous yellow depending on the priority of the alarm. When the button is pressed, the alarm, the alarm code and the troubleshooting in- structions will appear (chapter 17.5: Driving Unit Alarms, page 160).
  • Page 94 User Interface 1 Help display 2 Help button Fig. 7-7 Help window 1015002x00...

  • Page 95: Configuring And Operating The Driving Unit

    Configuring and Operating the Driving Unit Configuring and Operating the Driving Unit General This section describes all procedure steps that must be conducted on the EXCOR Active system. Handling of the sterile components, such as the blood pumps, is described in the EXCOR Sterile Components instructions for use. Heed the instructions for use on EXCOR sterile components! Switching On the System Connect the driving unit to the power supply.

  • Page 96: Checking Functionality Of A Configured Replacement Driving Unit

    Configuring and Operating the Driving Unit Check the following items on the driving unit: • Did the start test run without errors? • Are the displays active? • Can an audible alarm be heard when the buttons are pressed? Check the following items on the panel PC: •...

  • Page 97: Blood Pumps - Cannulae - Maximum Rate

    Configuring and Operating the Driving Unit Parameter Default value Type of synchronization Synchronous mode left right Rate 20 bpm 20 bpm Duration systole 50 % 50 % Flow alarm threshold No preset value Tab. 8-1 Default driving unit settings 8.4.2 Blood Pumps - Cannulae - Maximum Rate Cannulation Blood pump...

  • Page 98: Configuring The System

    Configuring and Operating the Driving Unit Configuring the System WARNING Only configure blood pumps and cannulae that are being used. Deviat- ing settings could lead to the patient receiving insufficient support. If there is no way of adjusting insufficient driving unit settings, take al- ternative corrective actions immediately.

  • Page 99: Configuring A Driving Unit - Manual

    *. If no weight is entered, a recommendation cannot be dis- played. There may not be any information provided to the effect that the selected pump-cannula combination does not conform to the recommenda- tions of Berlin Heart. Accept entry. Press button.

  • Page 100: Selecting Settings For The Driving Unit

    When using cannulae with multiple diameters, or when using a con- necting set, always use the smaller lumen. Accept entry. If the pump-cannula combination selected does not conform to Berlin Heart recommendations, a message will appear. Nonetheless, any permissible combination can be selected.

  • Page 101: Checking Settings And Transferring To The Driving Unit

    Configuring and Operating the Driving Unit Continue with chapter 8.5.2.5: Checking Settings and Transferring to the Driv- ing Unit, page 101 8.5.2.5 Checking Settings and Transferring to the Driving Unit Switch to the view. ETTINGS Carefully check the settings. If settings need to be changed, switch to the appropriate view and make the necessary changes.

  • Page 102: Airing, Starting, And Setting The Blood Pumps

    Configuring and Operating the Driving Unit De-Airing, Starting, and Setting the Blood Pumps WARNING Do not set blood pumps solely on the basis of achievable and displayed flow. Always check that the new blood pump is filling and emptying completely. Select a suitable systolic duration. The goal is to generate sufficient flow for the patient’s needs, while also ensuring that the blood pump fills and empties completely.

  • Page 103: Bvad

    Configuring and Operating the Driving Unit Every start of a blood pump begins with a step. The first step is always a diastole. If the membrane of the blood pump is in the diastolic end position, membrane movement cannot be observed.

  • Page 104: Setting Rate And Synchronization

    Configuring and Operating the Driving Unit To stop the blood pumps, the button must be TART pressed once again. Press the corresponding button to stop the blood pumps. Only both blood pumps or the right blood pump can be paused. The blood pumps can be restarted with The start of the pumps is thus concluded.

  • Page 105: Optimizing The Filling And Emptying Of The Blood Pumps

    Configuring and Operating the Driving Unit 8.6.5 Optimizing the Filling and Emptying of the Blood Pumps 8.6.5.1 Blood Pump Phases Movement of the membrane to the diastolic end position in order to fill the blood pump. 1. Suction of blood 2.

  • Page 106: Piston Stroke And Mean Driving Pressure

    Configuring and Operating the Driving Unit membrane can reach the end position very quickly and pause in the respective end position. This can increase the risk of the formation of deposits. 3. By default, the parameter Duration systole is set to 50 %. If changes to Filling Emptying result in the system no longer being able to completely fill or empty...

  • Page 107: Setting The Parameter Duration Systole

    Configuring and Operating the Driving Unit Increase or decrease the filling and/or emptying by tapping on the buttons. After every tap, the system requires a short period of adjust- INUS ment. No additional settings can be changed during that period. Buttons can- not be selected until the system has finished self-regulation.

  • Page 108: Resetting The Driving Unit

    Configuring and Operating the Driving Unit Swipe to switch quickly between the views. ARAMETER RESSURE URVES Setting parameters Viewing and assessing changes 8.6.8 Resetting the Driving Unit reverts driving parameters to their default values. ESET DRIVING UNIT ESET DRIV can only be selected when the blood pumps are stopped. After the reset, ING UNIT the user arrives at the view.

  • Page 109: Setting A Flow Alarm Threshold

    Configuring and Operating the Driving Unit 8.7.2 Setting a Flow Alarm Threshold WARNING Set the flow alarm threshold for each patient individually; check it and adjust it as needed. If the flow alarm threshold is set too low, it can re- sult in insufficient patient support not triggering alarms.

  • Page 110: Postoperative

    Configuring and Operating the Driving Unit 1 Lower threshold for the flow alarm 2 Currently selected value 3 Upper threshold for the flow alarm Set the flow alarm threshold value and use to confirm. PPLY Note: If no flow alarm threshold is selected, an alarm will be emitted after 5 minutes if the rate is 60 bpm or higher.

  • Page 111: Mobilizing Patients

    Configuring and Operating the Driving Unit Parameter Auto operation Blood pump(s) stopped Operating mode Operating modes can only be changed after the driving unit is reset. Cannula sizes Cannula sizes can be only changed after the driving unit is reset. Tab.

  • Page 112: Changing The Blood Pump Size

    Configuring and Operating the Driving Unit Checking support while moving Ask patient to walk for at least 10 min. If filling / emptying worsens, adjust the parameters. Monitoring Monitor filling / emptying behavior again after one hour. Adjust the parameters if necessary. 8.8.4 Changing the Blood Pump Size The size of the blood pump can only be changed when the blood pump has been...

  • Page 113: Changing The Operating Mode

    Configuring and Operating the Driving Unit Switch to the view and de-air the blood pump(s) in sin- LOOD PUMP SETTINGS gle-step operation. After completely de-airing the blood pump(s), start the blood pump(s). 8.8.5 Changing the Operating Mode The operating mode can only be changed when the blood pumps are stopped and the driving unit has been reset.

  • Page 114: Replacing And Upgrading The Blood Pump

    Configuring and Operating the Driving Unit Replacing and Upgrading the Blood Pump Heed the instructions for use on EXCOR sterile components! WARNING Before switching to a different blood pump size, check whether a differ- ent flow sensor will be required. Information on which sensors can be used with which pumps and cannulae is available here: Tab.

  • Page 115: Replacing The Blood Pump - Bvad Right

    Configuring and Operating the Driving Unit In the event of a blood pump upgrade: See chapter 8.8.4: Changing the Blood Pump Size, page 112, steps 5 and 6. 10. Start the blood pump. 11. Check the filling and emptying of the blood pump and optimize if necessary. 12.

  • Page 116: Replacing The Driving Tube

    Configuring and Operating the Driving Unit 13. Mount the flow sensors and cable protectors. 14. Log off. 8.10 Replacing the Driving Tube Heed the instructions for use on EXCOR sterile components! Replacement of the driving tube is only described here in terms of the work steps to be performed on the driving unit and panel PC.

  • Page 117: Replacing Driving Tubes - Bvad Right

    Configuring and Operating the Driving Unit 8.10.2 Replacing Driving Tubes - BVAD Right Initial state: System in operation. The panel PC is connected to the driving unit. Driving tube with blue color coding is ready. Log in with the user profile. XPERT Remove the cable wrap.

  • Page 118: Replacement Driving Unit - Updating Configuration

    Configuring and Operating the Driving Unit In the view, press the but- ONFIGURATION EPLACEMENT ton. Replacement driving units can only be configured using function. This is the only function that EPLACEMENT will yield a driving unit that immediately commences pump operation in the event of an emergency, as soon as it is supplied with power.

  • Page 119: Types Of Data

    Configuring and Operating the Driving Unit Connect the panel PC to the driving unit. If necessary, plug the USB stick into the panel PC. Wait until the panel PC has connected to the replacement driv- ing unit. Log in with the user profile.
  • Page 120 Configuring and Operating the Driving Unit Automatically importing logs This function copies log data onto the panel PC as soon as the panel PC is connected to the driving unit. Log files that are already on the panel PC are not re-imported. Connect the driving unit to the panel PC.
  • Page 121 Configuring and Operating the Driving Unit Exporting the configuration This function copies the selected configuration to the connected USB stick. The se- lected configuration is always one that is saved on the panel PC. Log in. Connect the USB stick to the panel PC. Only one USB stick may be inserted into the panel PC.
  • Page 122 Configuring and Operating the Driving Unit 1015002x00...

  • Page 123: Replacing The Driving System

    Replacing the Driving System Replacing the Driving System General This section describes all steps that must be performed on the driving unit of the EXCOR Active system. Make sure to consult the Ikus instructions for use regarding actions to take on the Ikus and configuration of that driving system. Heed the instructions for use on the EXCOR driving system! For information and specifications on blood pumps and cannulae, be sure to consult the EXCOR Sterile Components instructions for use.

  • Page 124: Switching To Excor Active

    Replacing the Driving System Configure the driving unit, see section 8.5: Configuring the System, page 98. Transfer the following parameters from Ikus to EXCOR Active (for each sup- ported side in BVAD mode): • Operating mode • Cannula sizes • Size of the blood pump •...

  • Page 125: From Excor Active To Ikus

    Replacing the Driving System From EXCOR Active to Ikus 9.3.1 Preparing the Ikus Switch on and configure the Ikus, see the Ikus instructions for use. Transfer the EXCOR Active driving parameters to the Ikus. The following parameters are transferred (for each supported side in BVAD mode): •...
  • Page 126 Replacing the Driving System 1015002x00...

  • Page 127: Weaning And Explantation

    Weaning and Explantation Weaning and Explantation 10.1 General This section describes all procedure steps that must be conducted on the driving unit. Handling of the sterile components, such as the blood pumps, is described in the EXCOR Sterile Components instructions for use. 10.2 Weaning the Patient Longer periods of blood pump stoppage or blood pump operation at a very low rate are both unfavorable in terms of hemostasis and risk of thrombogenesis.
  • Page 128 Weaning and Explantation 1015002x00...

  • Page 129: Performing Trainings

    Performing Trainings Performing Trainings 11.1 Target Group for Trainings 11.1.1 Qualified Medical Personnel The manufacturer offers training sessions for qualified medical personnel. Contact the manufacturer or the distributor to schedule training dates, see chapter 1: Contact, page 13. 11.1.2 Lay Users EXCOR Active is suitable for use by users without specific medical knowledge.

  • Page 130: Training Content Checklists

    Performing Trainings Caregivers supervising patients who do not understand how to operate the system safely must undergo training, because those patients re- quire continuous monitoring. 11.3 Training Content Checklists 11.3.1 Using Components Training of patient and caregivers Check Function Functionality of the driving unit Connecting components Calling up display views and knowing what they mean Connecting the driving unit to mobile components...

  • Page 131: Behavior And Safety

    Performing Trainings Training of patient and caregivers Check Flow sensors Attaching and detaching flow sensors Attaching and detaching the cable wrap Sensor locking clip - flow sensor color marking Corrective actions in the event of a defective flow sensor (Contact the hospital and have the defective flow sensor replaced) Information on components by other manufacturers Using the stroller / baby seat components Safety information regarding strollers / baby seats...

  • Page 132: Training Log

    Performing Trainings Safety Check Contact person Hospital Psychological support Caregiver Special environmental conditions - identifying dangers Stairs Bathroom Kitchen Mobility Maneuvering in public areas and recognizing dangers 11.4 Training Log Training Check section 11.3.1: Using Components, page 130 section 11.3.2: Behavior and Safety, page 131 Contents and instructions as described in the Instructions for patient and caregiver use Physician name...

  • Page 133: Mobile Use Of Excor Active

    Mobile Use of EXCOR Active Mobile Use of EXCOR Active 12.1 Help with Mobilization The following components are available for use when mobilizing the patient: • Caddy, chapter 13: Caddy, page 135 • Baby Buggy, chapter 15: Baby Buggy - Stroller Board, page 143 Fig.
  • Page 134 Mobile Use of EXCOR Active 1015002x00...

  • Page 135: Caddy

    Caddy Caddy 13.1 Setup 1 Handle 2 Hand strap 3 Clip for driving tubes 4 Mounting hook 5 Mounting bracket for accessory bag 6 Brake 7 Stand 8 Locking bolt to release the locking mecha- nism 9 Mount 10 Wheel locking mechanism 11 Wheel Fig.

  • Page 136: Mounting - Dismounting The Wheels

    Caddy Unfold the stand to the stop posi- tion and allow the locking handle to snap into place. 13.2.2 Mounting - Dismounting the Wheels In order to mount the wheels, the stand must be folded open. Mounting: Press the wheel lock- ing mechanism inwards and attach the wheel in the process.

  • Page 137: Attaching The Accessory Bag

    Caddy 13.2.4 Attaching the Accessory Bag Grip the accessory bag by the handle such that the fasteners are open. Hang the accessory bag from the hook below and the fasteners from the crossbar above. Release the handle. Make sure that the accessory bag is seated firmly.

  • Page 138: Using The Caddy

    Caddy Release the clips before repositioning the driving tubes, see section 13.3.3: Securing and Releasing the Driving Tubes, page 139. Press the lock release on both sides. Press and hold the lock release, and slide the handle to the desired height. Let go of the lock release.

  • Page 139: Securing And Releasing The Driving Tubes

    Caddy 13.3.3 Securing and Releasing the Driving Tubes Lay the driving tubes such that they will not tangle on the wheels or drag on the ground when in motion. Press the driving tubes into the clips. To release the driving tubes, pull them out of the clips.
  • Page 140 Caddy Remove the driving unit. Remove the wheels. Fold and lock the stand. Slide the handle downwards. Fig. 13-2 Caddy in transport position 1015002x00...

  • Page 141: Accessory Bag

    Accessory Bag Accessory Bag 14.1 Design and Function 4 Closure 1 Valves with magnetic closure 5 Handle and opening contact for the locking 2 Battery compartment mechanism 3 Pump compartment 6 Grommets for mounting bracket 14.2 Packing the Accessory Bag WARNING The accessory bag contains components that increase safety during mobile use.
  • Page 142 Accessory Bag 2 Manual pump 1 Two charged batteries 3 Short instructions 4 Tire pump for caddy 1015002x00...

  • Page 143: Baby Buggy - Stroller Board

    WARNING The stroller board may only be connected to a stroller that has been ob- tained from Berlin Heart. Otherwise, secure connections and safe us- age cannot be guaranteed. Activate the brake whenever the transport system is not in motion. The brake prevents the caddy from rolling away accidentally.
  • Page 144 Baby Buggy - Stroller Board Body Carrier Wheel Countersunk screw Hook for bag Hexagon screw Sleeve Spacer set Stroller clip Allen wrench 3 mm 1015002x00...

  • Page 145: Overview - Assembly

    Baby Buggy - Stroller Board 15.4.2 Overview - Assembly 1 Hexagon screw 5 Countersunk screw 2 Hook for bag 6 Cap 3 Sleeve 7 Body 4 Carrier 8 Wheel Fig. 15-2 Stroller board assembly 1015002x00...

  • Page 146: Mounting The Stroller Board

    The manufacturer’s instructions for use are included with each compo- nent. Take note of all instructions and safety information given in the in- structions for use. Strollers and child seats that are compatible with the stroller board can be ordered from Berlin Heart. 1015002x00...

  • Page 147: Set 1 - Frame

    Baby Buggy - Stroller Board 15.4.5.1 Set 1 - Frame 1 Base frame 3 Sunshade 2 Set of wheels 15.4.5.2 Set 2 - Child Seat Fixture with Accessories 3 Cover 1 Child seat 4 Rain protection 2 Frame 5 Brackets 15.4.5.3 Set 3 - Baby Seat Fixture 1 Rain protection 3 Baby seat adapter...

  • Page 148: Attaching The Stroller Board To The Stroller

    Baby Buggy - Stroller Board 15.4.6 Attaching the Stroller Board to the Stroller Mount the spacers onto the rear axle. To do so, place two spacers around each axle and press them tight. Position as shown in the diagram. Press the snap-in connectors of the stroller board over the rear axle.

  • Page 149: Positioning The Driving Tubes

    Baby Buggy - Stroller Board Activate the brake on the stroller. Hang the bag on the stroller board. Attach the driving unit. Check the locking mechanism. Sit or lay the patient into the stroller. Position the driving tubes and secure them with the stroller clips. Adjust the position of the stroller clips if needed.
  • Page 150 Baby Buggy - Stroller Board Fig. 15-3 Guiding of the driving tubes 1015002x00...

  • Page 151: Manual Pump

    Manual Pump Manual Pump 16.1 General In a case of emergency, the manual pump can temporarily replace a driving unit. The manual pump shall be operated by medical personnel trained in the use of the manual pump. Pumping for long periods of time is strenuous. Ideally, two persons will need to alter- nate operating the manual pump.

  • Page 152: Setup

    Manual Pump 16.3 Setup 1 Handle 2 Connection for blue driving tube 3 Valves; one negative pressure valve and one overpressure valve per side 4 Base plate 5 Connection for red driving tube 6 Plug Fig. 16-2 Composition of the manual pump 1 Color marking red to red 2 Area above the release sleeve, fixed 3 Release sleeve, movable...

  • Page 153: Supporting The Patient With The Manual Pump

    Manual Pump 16.4 Supporting the Patient with the Manual Pump Two-handed operation One-handed operat Fig. 16-4 Support from the manual pump Lay the patient on his or her back. Remove the seal plugs from the driving tube connections. Always remove both plugs.
  • Page 154 Manual Pump 1015002x00...

  • Page 155: Identifying Errors And Troubleshooting

    Identifying Errors and Troubleshooting Identifying Errors and Troubleshooting 17.1 Safety Information WARNING Immediately replace any components if they malfunction in a manner that cannot be rectified by the user! Replace components even if the malfunction does not put patient sup- port at immediate risk.

  • Page 156: Driving Unit And Panel Pc Alarms

    Identifying Errors and Troubleshooting 17.3 Driving Unit and Panel PC Alarms 17.3.1 Alarms If an alarm condition develops, an alarm will be emitted: Driving unit Panel PC External alarm Message Message and Detailed mes- Forwarding of instructions on sage and high- and the display instructions on...

  • Page 157: Perceiving Alarms Reliably

    Identifying Errors and Troubleshooting Priority Driving unit Panel PC medium yellow flashing system yellow flashing bell, alarm LED or battery LED code on yellow back- ground slow tone sequence every 7.5 seconds continuously illuminated continuously illuminated yellow system LED, bat- yellow bell, alarm code on tery LED or maintenance white background...

  • Page 158: Audible Alarms On The Driving Unit

    Identifying Errors and Troubleshooting Display and meaning twice every LASHING RED second High priority alarm every two LASHING YELLOW seconds Medium priority alarm continuous LLUMINATED YELLOW Low priority alarm Tab. 17-3 Visual displays on the driving unit 17.3.7 Audible Alarms on the Driving Unit When an alarm condition occurs, an audible alarm is emitted.

  • Page 159: Audio Off

    Identifying Errors and Troubleshooting 17.3.8 Audio Off Audible alarms are switched off when the user is logged in as UDIO OFF XPERT and one or both blood pump(s) is/are paused or has/have not been started. EDICAL Fig. 17-1 Audio off 17.3.9 Saving Configurations and Logs Driving unit The driving unit is equipped with internal memory.

  • Page 160: Driving Unit Alarms

    Identifying Errors and Troubleshooting Notice the alarm. Pause audio. Do this by pressing the <but- ton> on the driving unit. Read the message and instructions on the display. Check if any other alarms are being sig- naled. Check both displays. 1 Press the button Work through the instructions for action, 2 Read the alarm message...
  • Page 161 Identifying Errors and Troubleshooting Code and Message Instructions Information in the priority instructions for Pressure loss Check driving tube and section 5.2.2.2, plug page 39 section 17.7, page 165 Flow too low Check the driving tube, section 17.7, blood pump and cannulae page 165 Battery dis- Replace battery or con-...

  • Page 162: Panel Pc Alarms

    Identifying Errors and Troubleshooting Code and Message Instructions Information in the priority instructions for Pressure Check and seal pneu- build-up not matic connection possible Flow sensor Connect flow sensor section 5.2.3.6, not connected page 46 Flow sensor Immediately disconnect section 5.2.3.6, defective the flow sensor, notify page 46...
  • Page 163 Identifying Errors and Troubleshooting Code and Message Instructions priority Pressure loss <left/ Check the connection of the <left/right> right>! driving tube to the blood pump and to the driving unit. Flow <left/right> too Check the driving tube, the blood pump low! and the cannulae.

  • Page 164: Panel Pc Messages

    Identifying Errors and Troubleshooting Code and Message Instructions priority Flow monitoring not Set threshold value for the flow alarm. ready Driving unit too hot! Search for a cooler environment imme- diately. Driving unit too cold! Search for a warmer environment imme- diately.

  • Page 165: Alarms H1 And H2

    Identifying Errors and Troubleshooting 17.7 Alarms H1 and H2 alarms indicate possible insufficient patient support. When these alarms occur, check the following: 1. Are the blood pumps filling and emptying completely? 2. Are the driving tubes plugged into the driving unit securely? 3.

  • Page 166: P6 Emergency Battery In Use

    Identifying Errors and Troubleshooting 17.9 P6 Emergency Battery in Use When the emergency battery is active, immediately insert charged batteries and/or es- tablish a mains power connection. When the P7 MERGENCY BATTERY DISCHARGED alarm is emitted, the emergency battery has a remaining operating time of 30 minutes. If only partially charged batteries are inserted, the alarm may not be canceled.

  • Page 167: Errors Without Messages

    Identifying Errors and Troubleshooting When a T5 alarm ) or a alarm LOW SENSOR TOO WARM LOW SEN ) occurs, the temperature of the flow sensor is too high. SOR TOO HOT Seek out a cooler environment immediately. Remove coverings that could prevent heat dissipation (such as clothing or bed linens) from the flow sensor.

  • Page 168: Unexpected Changes In Functionality

    Identifying Errors and Troubleshooting Error Removal Missing or illegible inscriptions or safety Notify contact person. symbols Display failure Replace the driving unit. Display frozen, activity symbol showing Failure of backlight <Button> on driving unit does not respond or is permanently on Changes to audible alarms indicate fail- ure of an alarm module.
  • Page 169 Identifying Errors and Troubleshooting Find the defect. This may require removal of the cable wrap. Wipe away any contamination. Do not introduce any contamination or fluids into the damaged area. Wrap the damaged area with air-tight adhesive tape. Check the flow. Improve on the repair, if required. 1015002x00...
  • Page 170 Identifying Errors and Troubleshooting 1015002x00...

  • Page 171: Maintenance, Cleaning And Disinfection

    Maintenance, Cleaning and Disinfection Maintenance, Cleaning and Disinfection 18.1 Safety Information WARNING Observe the prescribed maintenance intervals. If these warnings are not heeded, safe and smooth operation is not guaranteed. Do not conduct service or maintenance work on components that are actively being used on patients.

  • Page 172: Inspections By The Operator

    Maintenance, Cleaning and Disinfection Component Packaging Driving unit and batteries Driving unit case Replacement driving unit Manual pump Flow sensor Packaging for flow sensor Caddy Components case Tab. 18-2 Intended packaging 18.2.3 Inspections by the Operator 18.2.3.1 Intervals Component Interval Panel PC Annually Power supply units...

  • Page 173: Docking Station

    Maintenance, Cleaning and Disinfection 18.2.3.4 Docking Station Functional test • Check of external integrity • Check of display and connections 18.2.3.5 Battery Charging Unit Functional test • Check of external integrity • Check of display and connections 18.3 Cleaning and Disinfection WARNING Between uses, clean and disinfect components that are intended for use on multiple patients.

  • Page 174: Cleaning Agents And Disinfectants, Resources

    Maintenance, Cleaning and Disinfection Cleaning Moisten a cloth with water and wipe down all exterior surfaces. If necessary, use a mild, pH-neutral cleaning agent. Larger particles can first be removed using a soft brush. If using cleaning agents: Wipe down all surfaces with a damp cloth to remove any residue.
  • Page 175 Maintenance, Cleaning and Disinfection Fixed intervals for contact Cleaning areas and functional areas - every... days before the component is Disinfection used by another patient If necessary, if contamina- tion is visible Component When? Cleaning / disinfection Flow sensor including At each dressing change protective cap, sensor quick connect and...

  • Page 176: Notes On Cleaning And Disinfecting Components

    Maintenance, Cleaning and Disinfection 18.3.4 Notes on Cleaning and Disinfecting Components Component Notes on cleaning and disinfection Flow sensor including Check the flow display and note values. protective cap, sensor Remove the flow sensor from the cannula. locking clip, and sen- Remove the sensor quick connect and the protective sor quick connect cap from the flow sensor.

  • Page 177: Performing Functional Tests

    Maintenance, Cleaning and Disinfection Component Notes on cleaning and disinfection Battery Remove the battery from the driving unit or battery charging unit. Only remove one battery from the driving unit at a time. Do not immerse the battery. Cover electrical contacts. Battery charging unit Disconnect the battery charging unit from mains power.

  • Page 178: Overview Of Regular Actions

    Maintenance, Cleaning and Disinfection Component When? Execution Alarm module: On the driving unit control panel: Check of audible Press and release the left <button> alarms Press and release the right <button> Result The functional test is passed if, when both the left and right <buttons> are pressed, an audible tone is emitted.
  • Page 179 Maintenance, Cleaning and Disinfection When? What / Where? Action Every four hours Cannulae Check for deposits and defects Blood pump Check for deposits and defects Check for complete filling and emptying Driving unit Check list of emitted alarms Daily Alarm module Alarm module functional test When changing Transcutaneous...
  • Page 180 Maintenance, Cleaning and Disinfection 1015002x00...

  • Page 181: Scope Of Delivery And Transport Cases

    Scope of Delivery and Transport Cases Scope of Delivery and Transport Cases WARNING System components must only be transported or shipped in their in- tended transport cases / packaging. Otherwise, safe and proper trans- portation of the components is not guaranteed. 19.1 Contents of the Components Case Pos.

  • Page 182: Contents Of The Driving Unit Case

    Scope of Delivery and Transport Cases 11 12 Fig. 19-1 Contents of the components case Pack the case as shown in the diagram. 19.2 Contents of the Driving Unit Case The driving unit case contains the driving unit, the batteries, and the manual pump. The specific driving unit model varies by approval region.

  • Page 183: Flow Sensor Set Contents

    Scope of Delivery and Transport Cases Pack the driving unit, batteries, and manual pump into the driving unit case as shown in the figure. 1 Manual pump 2 Driving unit 3 Battery 1 Pull-out handle 2 Grommet for sealing the box 3 Lock Fig.
  • Page 184 Scope of Delivery and Transport Cases Flow sensor set Quantity Cable wrap including wrapping tool 1505100 Accompanying documentation Flow sensor set 2 - FS09-09-P 1505010 Flow sensor FS09-09-P Replacement parts set FS09, consist- 1505120 ing of: - Sensor quick connect FS09 - Sensor locking clip FS09 - Protective cap Cable wrap including wrapping tool...

  • Page 185: Optional Components

    Scope of Delivery and Transport Cases Flow sensor set Quantity Cable wrap including wrapping tool 1505100 Accompanying documentation Flow sensor set 5 - FS09-12-C 1505040 Flow sensor FS09-12-C Replacement parts set FS12, consist- 1505130 ing of: - Sensor quick connect FS12 - Sensor locking clip FS09 - Protective cap Cable wrap including wrapping tool...
  • Page 186 Scope of Delivery and Transport Cases Pos. Component Quantity Child seat fixture with accesso- 1550202 ries Baby seat fixture 1550203 Tab. 19-4 Optional components 1015002x00...

  • Page 187: Technical Specifications

    Technical Specifications Technical Specifications 20.1 Driving Unit Parameter Value Weight approx. 12 kg Weight with batteries approx. 14.4 kg Dimensions (L x W x H) 326 mm x 218 mm x 398 mm Protection class (Protection against electric shock) Input voltage 19 V DC Power consumption 110 VA...

  • Page 188: Flow Sensor

    Technical Specifications Nominal voltage 14.4 V DC Nominal capacity 6.0 Ah Capacity 86.4 Wh Charging time max. 7h in driving unit max. 3h in battery charging unit Protection type, ingress protection IP 53 (dust-protected, protected against spray- ing water) Tab. 20-2 Battery 20.3 Flow sensor Parameter Value...

  • Page 189: Panel Pc And Docking Station

    Technical Specifications Output current max. 9.47 A Protection class Tab. 20-4 Power Supply Unit for Driving Unit and Battery Charging Unit 20.5 Panel PC and Docking Station Parameter Value Weight 1.2 kg Dimensions (L x W x H) 295 mm x 199 mm x 23 mm Input voltage 18 V DC...

  • Page 190: Battery Charging Unit

    Technical Specifications Weight approx. 1.1 kg Dimensions (L x W x H) 261 mm x 185 mm x 104 mm Input voltage 18 V DC Input current 3.5 A Protection class Tab. 20-5 Panel PC, docking station, power supply unit for panel PC 20.6 Battery Charging Unit Parameter Value...

  • Page 191: Packaging

    Technical Specifications Weight approx. 1.0 kg Dimensions (L x W x H) 157 mm x 328 mm x 346 mm Weight 3.6 kg 559 mm x 542 mm x Dimensions 652 mm (mounted) Tab. 20-7 Caddy, Stroller Board 20.8 Packaging Parameter Value Weight...

  • Page 192: Ambient Conditions

    Technical Specifications 20.9 Ambient Conditions All specified air humidity values refer to non-condensing environmental conditions. 20.9.1 Operating Conditions The following operating conditions apply to EXCOR Active. Components Temperature Air humidity Pressure Mobile: 1060 hPa 98 % 40 °C Driving unit includ- ing battery - 10 °C 15 %...

  • Page 193: Storage Conditions

    Technical Specifications 20.9.2 Storage Conditions The following storage conditions apply to EXCOR Active. They refer to the conditions at which components are to be stored for potential immediate use. Temperature Air humidity Pressure 1060 hPa 90 % 40 °C 10 °C 600 hPa 20 % Tab.
  • Page 194 Technical Specifications 1015002x00...

  • Page 195: Overview - Parameters

    Overview - Parameters Overview - Parameters Not all parameter values can always be selected - availability depends on the driving unit model (see section 3.3: Scope of Driving Unit Functionality, page 20) and the spe- cific parameter. Example: if a 10 mL blood pump has been selected, 12 mm cannulae will not be available for selection.

  • Page 196: Permitted Combinations Of Blood Pumps And Cannulae

    Overview - Parameters 21.3 Permitted Combinations of Blood Pumps and Cannulae Size of the blood pump Inflow cannula [mm] Outflow cannula [mL] [mm] 6 with connecting set 5 with connecting set 6 with connecting set 6 with connecting set 6 with connecting set 6 with connecting set 6 with connecting set 6 with connecting set...
  • Page 197 Overview - Parameters Parameter Value Child protection on, off Time of self-test Freely selectable down to the minute Tab. 21-4 Patient and driving unit parameters 1015002x00...
  • Page 198 Overview - Parameters 1015002x00...

  • Page 199: Using The External Alarm (Nurse Call)

    Using the External Alarm (Nurse Call) Using the External Alarm (Nurse Call) 22.1 Assembling the External Alarm (Nurse Call) Adapter Before using the external alarm (nurse call), the hospital must put a connector in place. The required connector plug is included in delivery and can be assembled by the hospital's qualified personnel.
  • Page 200 Using the External Alarm (Nurse Call) Electrical data The contacts are de-energized. Rated voltage maximum 60 V Rated current maximum 3 A 1015002x00...

  • Page 201: Emc

    In case of doubt, please contact Berlin Heart. 23.2 Major Performance Characteristics The following essential performance characteristics have been tested, and are valid even under the influence of electromagnetic disturbances: •...

  • Page 202: Electromagnetic Emissions

    ting high-priority alarms with the following characteristics: The tone sequence for the high-priority alarm is recognizable, and the corresponding LED flashes red. • No disruptions in communication between the panel PC and the driving unit oc- cur, or no more than one temporary (max. 5 s) disruption occurs (e.g., due to high-frequency surgery).

  • Page 203: Electromagnetic Immunity, Part 1

    23.4 Electromagnetic Immunity, Part 1 Guidance and manufacturer's declaration – electromagnetic immunity EXCOR Active is intended for use in an electromagnetic environment as specified below. The customer or user of EXCOR Active must ensure that EXCOR Active is used in such an envi- ronment.

  • Page 204: Electromagnetic Immunity, Part 2

    23.5 Electromagnetic Immunity, Part 2 Guidance and manufacturer's declaration – electromagnetic immunity EXCOR Active is intended for use in an electromagnetic environment as described below. The customer or user of EXCOR Active must ensure that EXCOR Active is used in such an environment.
  • Page 205 Guidance and manufacturer's declaration – electromagnetic immunity EXCOR Active is intended for use in an electromagnetic environment as described below. The customer or user of EXCOR Active must ensure that EXCOR Active is used in such an environment. Immunity tests IEC 60601 test Level of compli- Electromagnetic environ-...
  • Page 206 1015002x00...

  • Page 207: Patient Id Labels

    Patient ID Labels Patient ID Labels Configured replacement driving units must be clearly labeled so that they can be de- finitively associated with a patient. There is a tray for the patient ID on the rear side of the driving unit. If the original label is already filled in, feel free to copy and use this label template.
  • Page 208 Patient ID Labels 1015002x00...

  • Page 209: Abbrevations

    Abbrevations Abbrevations BVAD: Biventricular Assist Device CISPR: Special International Committee on Radio Interference (comité international spécial des perturbations ra- dioélectriques) CPB: Cardiopulmonary bypass EMC: Electromagnetic compatibility ESD: Electrostatic discharge HDD: Hard Disk Drive HF: High frequency IEC: International Eletrotechnical Commission LVAD: Left Ventricular Assist Device RVAD: Right Ventricular Assist Device 1015002x00...
  • Page 210 Abbrevations 1015002x00...
  • Page 211 Print Control A B C D E F G H I J K L M N O P Q R S T U V W X Y Z a b c d e f g h i m n o p q r u v w x y z >...
  • Page 212 1015002x00...

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